Trial | NCT01596855  Report issue

Title

Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    96
The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.
Dose ranging study with three consecutive dose escalation cohorts. The study objectives are to demonstrate that FG-4592 is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.
Study Started
Sep 30
2011
Primary Completion
Jan 31
2013
Study Completion
Jan 31
2013
Last Update
Feb 04
2013
Estimate

Drug FG-4592

TIW dosing, capsule

Drug Epoetin Alfa

TIW

FG-4592 Experimental

Active Drug

Epoetin alfa Active Comparator

Standard of care

Criteria 

Inclusion Criteria:

Subject has voluntarily signed and dated an informed consent form
Age 18 to 75 years
End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1
Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.

Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:

Epoetin alfa dose range for 6 weeks prior to Day -7:

3000 to 20,000 IU/week

Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period)
Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits
Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
Body weight: 40 to 100 kg (dry weight) inclusive
Body mass index (BMI): 16 to 38 kg/m2 inclusive
HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter)

Exclusion Criteria:

Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study
Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) > ULN during screening on two separate occasions,
Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
New York Heart Association Class III or IV congestive heart failure
Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
Active or chronic gastrointestinal bleeding, or a known coagulation disorder
Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
Active hemolysis or diagnosis of hemolytic syndrome
Known bone marrow fibrosis
Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)
Any prior organ transplantation
Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
Prior treatment with FG-4592
Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor
No Results Posted